AB0739 Aminaphtone tolerability and safety in scleroderma patients: a four-year follow-up
Authors: A. Cere, E. Gotelli, A. Lercara, C. Pizzorni, S. Paolino, E. Alessandri, M. Cutolo, A. Sulli
Journal: Annals of the Rheumatic Diseases (2022)

Background Recent studies show that Aminaphtone is effective in the treatment of Raynaud’s phenomenon (RP) symptoms in patients with systemic sclerosis (SSc), and an increase in peripheral blood perfusion was demonstrated by Laser speckle contrast analysis in treated patients (1,2). Unfortunately, the drug is only available in a few countries. Objectives To evaluate long-term tolerability and safety of Aminaphtone in SSc patients with secondary RP. Methods Seventy SSc patients (EULAR/ACR criteria) (mean disease duration 8±7 years, mean age 61±10 years) who started Aminaphtone treatment due to active RP were enrolled and followed for at least 4 years. Patients were also taking various concomitant treatments, including immunomodulators, cyclic intravenous iloprost, endothelin receptor antagonists and aspirin. None was taking sildenafil or selexipag. Survival of Aminaphtone in therapy was assessed along with possible drug-related side effect. The Raynaud condition score (RCS) to asses disease severity and blood examinations were routinely performed. Results The mean follow-up of patients was 49±11 months. Aminaphtone was orally administered at 75 mg twice daily, as standard initial posology in our clinical practice. During the follow-up, six patients (8,6%) referred headache as side effect and had to reduce Aminaphtone posology to 75 mg per day, while maintaining clinical benefits. No other side effect related to the drug was observed during the follow-up. Seven patients increased the posology to 75 mg three times daily due to poor effectiveness, and further seven patients increased the posology to 75 mg three times daily only during the colder months of the year. Conversely, thirty-five patients reduced the dosage to 75 mg once daily only during the hottest months of the year, due to partial remission of the RP. During follow-up, blood tests did not reveal any significant alteration ascribable to Aminaphtone. A subjective improvement of Raynaud’s symptoms (assessed by the RCS) was already evident after 1-2 months of treatment in fifty-six patients (80%). Globally, the patients referred a sustained improvement followed by stabilization of Raynaud’s symptoms during the follow-up. Conclusion During an average observation period of four years, Aminaphtone showed a good tolerability and safety profile along with sustained efficacy in patients with SSc-related RP, without disabling or serious side effects. A randomized controlled trial for Aminaphtone use in the management of SSc-related RP is desirable to better assess the clinical efficacy of the drug over time. References [1]Parisi S, et al. Am J Int Med. 2015;3:204–209. 2. Ruaro B et al. 2019. Front Pharmacol 10:293. Disclosure of Interests ANDREA CERE: None declared, Emanuele Gotelli: None declared, Adriano Lercara: None declared, Carmen Pizzorni: None declared, Sabrina Paolino: None declared, Elisa Alessandri: None declared, Maurizio Cutolo Grant/research support from: Bristol Myers Squibb, Celgene, Pfizer, Boehringer Ingelheim, Alberto Sulli: None declared